In a September 10 research note, Analyst Zegbeh Jallah, Ph.D. of ROTH Capital Partners LLC stated that just a few days ago, clinical stage biotech company Inventiva Pharma (IVA:FR-Paris; IVA:NASDAQ) announced that it had initiated its much-anticipated pivotal Phase 3 study of Lanifibranor (pan-PPAR) in nonalcoholic steatohepatitis (NASH).
The analyst commented that the new Phase 3 NATIVE3 study was supported by the stellar results from the 24-week Phase 2b NATIVE trial of Lanifibranor which met both NASH resolution and fibrosis improvement endpoints and served to greatly differentiate Lanifibranor from other similar drug candidates put forth by competitors. Lanifibranor is believed to offer potential broad benefits in NASH treatment including additional cardiovascular benefits that will be investigated further.
ROTH Capital Partners remains very optimistic and bullish on Inventiva's Lanifibranor program addressing NASH and points out to investors that additional data is expected to come forth in H1/22 from its clinical trials in patients with non-alcoholic fatty liver disease (NAFLD) and Type 2 diabetes (T2DM).
The analyst noted that the Phase 3 NATIVE3 trial evaluating Lanifibranor in NASH has been initiated and that enrollment of the first patients in the study is expected to begin this quarter.
The Phase 3 NATIVE3 is a randomized double-blind study designed to evaluate Lani 800 mg QD and 1200 mg QD versus placebo in F2 (moderate fibrosis) and F3 (advanced fibrosis) patients with NASH. Inventiva plans to enroll 900 participants in Part 1 of the NATIVE3 trial. The company expects "first patient, first visit this quarter and last patient, first visit in H2/22."
The report mentioned that the study has already been signed-off by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The studies primary composite endpoint has been pre-established as "NASH resolution and fibrosis (1-stage) improvement in patients with NASH at 72-weeks."
The analyst remarked that ROTH Capital believes that it expects Inventiva to be able to readily meet both endpoints which would provide a solid path forward for accelerated approval in the U.S. and conditional approval in the EU.
Inventiva is a clinical stage biotech firm that is currently engaged in creating oral small molecule therapies for diseases with unmet medical needs. The company is headquartered in France and is presently focused largely on advancing its primary lead clinical program, Lanifibranor in NASH, along with other medicines in its early-stage pipeline.
Lanifibranor was described in the report as a pan-PPAR agonist that is presently being studied in treatment of NASH patients and in diabetic patients with NAFLD. The firm is also currently conducting clinical programs addressing mucopolysaccharidosis and moderate to severe psoriasis.
ROTH Capital Partners advised that it has a "Buy" rating on Inventiva S.A. with a 12-month price target of €55/share. The firm said the target price was derived by employing discounted cash flow, net present value and sum of the parts valuation metrics to arrive at a value of €48 for Lanifibranor, €2 for Cedirogant, €2 for Odiparcil and €3 for net cash held.
The company's shares trade in France on the Paris Stock Exchange under the symbol "IVA" and last closed for trading at €11.32 on Tuesday, September 14, 2021. The firm's ADR shares also trade in the U.S. on the Nasdaq market under the same ticker symbol.
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Disclosures from ROTH Capital Partners, Inventiva S.A/ADR, Sep. 10, 2021
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal viewsabout the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
ROTH makes a market in shares of Inventiva S.A./ADR and Madrigal Pharmaceuticals and as such, buys and sells from customers on a principal basis.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used
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